The Daily Biotech Pulse: No Anxiety For Biohaven, Strongbridge's About-Face, Bristol-Myers Squibb's FDA Wait

Here's a roundup of top developments in the biotech space over the last 24 hours. 

Scaling the Peaks

(Stocks hitting 52-week highs on Aug. 15)

• Inspire Medical Systems Inc INSP
• Merck & Co., Inc. MRK
• Pacira Pharmaceuticals Inc PCRX

Down In The Dumps

(Stocks hitting 52-week lows on Aug. 15)

• Achieve Life Sciences Inc ACHV
• Aclaris Therapeutics Inc ACRS
• Aerpio Pharmaceuticals Inc ARPO (reported a wider Q2 loss)
• Aileron Therapeutics Inc ALRN
• Akebia Therapeutics Inc AKBA
• Alpine Immune Sciences Inc ALPN
• Auris Medical Holding AG EARS (reacted to Q2 results reported Wednesday before the market open)
• Biocept Inc BIOC (reported a revenue drop for Q2 but a narrower net loss)
• CELLECT BIOTECH/S ADR APOP
• ContraVir Pharmaceuticals Inc CTRV
• Cytori Therapeutics Inc CYTX (reported below-consensus Q2 results)
• DENTSPLY SIRONA Inc XRAY
• Erytech Pharma SA (ADR) ERYP
• Five Prime Therapeutics Inc FPRX
• Kala Pharmaceuticals Inc KALA
• La Jolla Pharmaceutical Company LJPC
• Melinta Therapeutics, Inc. MLNT
• NewLink Genetics Corp NLNK
• Nymox Pharmaceutical Corp NYMX
• Osiris Therapeutics, Inc. OSIR
• Portola Pharmaceuticals Inc PTLA
• Sellas Life Sciences Group Inc SLS(reported a wider-than-expected loss for Q2)
• SUMMIT THERAPEU/S ADR SMMT

See also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Earnings And IPOs

Stocks In Focus

Biohaven's Anxiety Drug Produces Positive Results In a Proof-Of-Concept Trial

Biohaven Pharmaceutical Holding Co Ltd BHVN said its BHV-0223, an experimental candidate to treat patients with social anxiety disorder and public speaking anxiety, met the primary endpoint in a proof-of-concept trial

"Trial results support further development of Biohaven's glutamate modulating platform as a potential novel treatment for anxiety disorders," the company said.

Strongbridge Terminates Plan To Offer Common Shares

Strongbridge Biopharma plc SBBP said it has cancelled its public offering of common shares announced Tuesday, citing its assessment that market conditions are not conducive for an offering on terms that would be in the best interest of its shareholders.

The stock rallied 10 percent to $5.56 in after-hours trading.

MiMedx Receives Additional Nasdaq Listing Notice

MiMedx Group Inc MDXG said it has received written notification from the Nasdaq for its failure to file its Form 10-Q for the quarter ended June 30, 2018. This is in addition to the notice it received previously for non-filing of Form 10-K for the period ended Dec. 31, 2017 and Form 10-Q for the period ended March 31, 2018.

The company said its listing will not be impacted until the panel hearing scheduled for Sept. 13, 2018.

The stock shed 3.27 percent to $3.85 in after-hours trading.

On The Radar

PDUFA Date

• Bristol-Myers Squibb Co BMY awaits an FDA nod for its sBLA for Opdivo to treat small-cell lung cancer.

Earnings

• Vascular Biogenics Ltd VBLT (before the market opens)

Related Link: Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates